FEBRUARY 18, 1998
AM Session
STATE OF MINNESOTA
DISTRICT COURT COUNTY OF RAMSEY
SECOND JUDICIAL DISTRICT
File No. C1-94-8565
The State of Minnesota, by Hubert H. Humphrey, III, its attorney general, and Blue Cross and Blue Shield of Minnesota,
Plaintiffs,
vs.
Philip Morris Incorporated, R.J. Reynolds Tobacco Company, Brown & Williamson Tobacco Corporation, B.A.T. Industries P.L.C., Lorillard Tobacco Company, The American Tobacco Company, Liggett Group, Inc., The Council for Tobacco Research-U.S.A., Inc., and The Tobacco Institute, Inc.,
Defendants.
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THE CLERK: Please rise. Ramsey County District Court is again in session, the Honorable Kenneth J. Fitzpatrick presiding.
THE CLERK: Please be seated.
THE COURT: Good morning.
MS. NELSON: Good morning, ladies and gentlemen.
KEVIN J. GRAHAM called as a witness, being previously sworn, was examined and testified as follows:
BY MS. NELSON:
Q. Good morning, Dr. Graham.
A. Good morning.
Q. Dr. Graham, yesterday we talked about a diagnostic procedure called a coronary angiogram. Do you recall that testimony?
A. Yes, ma'am.
Q. Turning your attention, then, to Exhibit 30028, which has been admitted for illustrative purposes, could you briefly remind the jury about the mechanisms of a coronary angiogram.
A. Yes, ma'am.
As we -- as we talked about yesterday, in patients who we consider high risk or who are in an unstable situation, we will take those patients to the coronary catheritization laboratory and -- and perform this procedure. If you --
And what we're going to look at this morning is, up here, where we're going to show some actual angiograms from -- that we see here in the room under the fluoroscope, and we'll show you a reproduction of the 35-millimeter films. But we enter in the right femoral artery down here, put that little tube in, that little sleeve that I showed you yesterday, put up either a left coronary catheter, which is shown here, or the right coronary catheter, which I showed you an example of yesterday, and then inject dye down the coronary arteries. Then we'll show some bypass grafts today to see, number one, if there are blockages present, number two, where they are, and number three, how severe they are. And our judgments to treatment are made based on those decisions.
Q. And doctor, when you perform angioplasties, the balloon procedure, or extraction atherectomies or rotoblade procedures, do you keep an angiogram going so you can photograph those procedures each time?
A. We make images of the -- that are then kept on one camera in the room -- or excuse me, on one monitor, and then we will play the artery, the exact same artery next to it as we do a procedure. What we call a road map. And -- and so when we're putting down our wire during the angioplasty procedure, we then know where to go, but then we keep giving little bumps of the contrast down there just to make sure we're where we need to be.
Q. Okay. Now have you put together a tape, which is Trial Exhibit 30011, of six different sets of angiograms?
A. Yes, ma'am.
Q. And can you briefly describe to the court and the jury what you did in compiling it?
A. I -- I tried to show a range of experiences that we would see in a typical day at the catheterization laboratory at the Minneapolis Heart Institute at Abbott Northwestern hospital. The experience is not different from what they would see at United Hospitals, St. Joe's here in St. Paul, at St. Cloud Hospital or the Duluth Clinic. We are lucky in being the largest provider, do approximately 30 to 40 of these cases a day, and -- and so when you're sitting at the bottom of a funnel, as it were, and see the highest-risk patients come through, you get a sense of what presents with real disease and what causes real disease not to show up.
With that, we will show you a range of -- from a totally normal angiogram to a severely diseased angiogram, with gradations in between there, also some of the procedures that we do in the catheritization laboratory.
Q. Doctor, will Exhibit 30011 assist you in illustrating your testimony to the jury?
A. Yes, ma'am.
MS. NELSON: Your Honor, we would offer 30011 for illustrative purposes only.
MR. MARTIN: Objection, Your Honor, for the reasons previously stated.
THE COURT: Court will receive 30011 --
MS. NELSON: If Your Honor --
THE COURT: -- for illustrative purposes.
MS. NELSON: With your permission, Your Honor, may the witness come down?
THE COURT: Yes.
MS. NELSON: Now because of the nature of this -- these tapes, they will not show on the overhead, so we'll have to have the jury look at their monitors to observe these tapes.
THE WITNESS: And we cannot dim the lights in the room at all?
MS. NELSON: No.
A. Okay. What --
The first patient I'm going to show you is -- is a normal coronary angiogram, and we -- just as my --
Can I flip this back? Is that okay?
Q. Sure.
A. Just to my very high-tech drawings here. The basics that you're going to see is the catheter injecting -- this is 25024 -- the left coronary system and the left anterior descending coming down the front of the heart, the circumflex artery circling around the back, and the right coronary artery going on the right side. So you'll see the different catheters, and I'll stop and explain as we go through what it is.
The first patient was a 45-year-old patient who had a -- a type of disease we call pericarditis, which is inflammation around the heart, was a non-smoker who was going to be taken actually to the operating room to remove part of his injured or inflamed sac around the heart, but needed a coronary angiogram before he went there, and it turned out this was normal. So we show it for -- to demonstrate what a normal angiogram looks like.
I'm going to be stopping this as we go along. I'll try and stop it.
Q. Okay. Get some technical assistance.
A. Okay. Get going -- let me go back here just a little bit. Okay.
We'll try it once again. As you'll see here, this is the big rope- like coronary arteries --
Q. Kevin, turn around and look at --
A. Excuse me.
Q. Okay.
A. This is the left anterior descending coming down the front of the heart, this is the circumflex, which actually is in the back of the heart. And we'll play these in several different projections. There is a camera that rotates around the patient's body in the catheterization laboratory, so just like a car looks different when you look at it from the front or the side or the back, the arteries of the heart also look the same. And as we -- as we then continue to rotate the camera, you can see actually the arteries of the heart filling.
This is the left anterior descending coronary artery, the big artery that comes down the front of the heart. And this is, here, seen in this projection here. And I'm just going to let this kind of play here now through. So you can see big, normal, juicy coronary arteries. Again the left anterior descending coming down the front of the heart there, and different projections as we swing. And there's that catheter injecting.
This is now the right coronary artery here, filling the bottom wall of the heart. If you -- this artery blocks off, you have what's called an inferior myo -- heart attack on the bottom wall of the heart.
This is the normal pumping function of the heart.
Q. And Dr. Graham, we see that pig tail clip in there.
A. And that has obvious reasons for that name. As you see the catheter there that is in the shape of a pig tail, that's -- again we present a blunt surface so that the -- as it comes up the aorta or if it sits in the ventricle, it doesn't injure the wall of the --
That is the aortic valve there. But you can see here, this is a normally pumping heart, which we call an ejection fraction, pushes the blood out vigorously. Okay.
This is in probably really counterdistinction to that, is a patient, 78- year-old patient from southern Minnesota who was a former smoker, quit approximately 10 years prior to presentation, was short of breath and had chest discomfort. And you will see as we look at -- at this angiogram here, that there are severe blockages all up and down the coronary tree, there, there, there.
This is now the right coronary artery, and you can see there that there's a severe blockage right there, here, here, all up and down the tree. And then we're going to take a couple pictures of the right coronary artery. And again I don't think you need to be a board certified cardiologist to see those severe, terrible blockages here.
Q. And the blockages are characterized, doctor, by what appears to be the interruption in the --
A. Right.
A. -- white clean artery; is that correct?
A. Right. You can see here and here, that black space, the blood is kind of having almost to line up single file to get through there. And this is this patient's right coronary artery, and then we will show the left system.
And we talked yesterday about the wheat field analogy that even after people stop smoking, there's been damage done, and you look here where his left anterior descending is, and you can see all up and down the artery here there are severe blockages. Actually the artery is -- is totally blocked off in a spot. And then starts again. This circumflex here has severe blockages all up and down it.
And again this is somebody who we would call has three-vessel disease. And you can see again -- I'm just going to let it run, if you -- again, you don't have to be a board certified cardiologist to see that, you know, that artery almost essentially stops and then starts again.
Q. And doctor, what do we observe about the strength of the left ventricle pumping in this?
A. We'll see in the ventriculogram here, the pumping shot -- we're just taking a number of shots, again, of how severe blockage is in these arteries. And we look then at this -- how this heart pumps is much, much different from that snappy, young heart. This ejection fraction -- normal again being about 15 -- or excuse me, 60 percent, we rated this one about 15 percent. And you can see the walls of the heart are just not squeezing in here. Okay?
Q. So the ejection fraction is a measure of the strength of the pumping; is that right?
A. Right. And so 60 being normal, this patient was about 15 percent.
This patient also presented with peripheral vascular disease. And again, this is the type of patient that we would see with congestive heart failure because the heart is not squeezing, the blood is not being pushed forward well, and then, because of the pressure increase to the heart, it backs up into the lungs. If there has been previous injury from smoking in the lungs, even if the patient does not have clinical COPD, the fact that there is no reserve in the heart and limited reserve in the lung tips these people over into a very, very kind of tenuous situation.
Because this patient also had problems with blockages or pain in the legs, which is peripheral vascular disease, we did -- when we finished the case, on the way out we did what's called a -- a --
This is the distal aorta down at the bottom where I talked about where it makes the Y to come down into the -- into the legs, to feed the legs down here. And you will see -- first of all, what will impress you? I'm going to run this through a couple times -- how slow the dye is going through there. It's just trickling. And this is because his heart is not beating very well. Then you will also notice that this looks almost like a LeMans speedway in that there's turns and twists in this, and this is from chronic blockages in the artery. But you can see the dye is just barely getting through, just puffing through instead of flowing in a laminar flow like hopefully yours and mine does. Okay?
I'm just going to go back and show that one more time because this is the only shot of peripheral vascular disease that we have.
But those are the legs -- those are the arteries that go to the legs. It's supposed to be a nice Y. You can see here the severe blockage here, the severe blockage down here, on both of these things here. And -- and again, be impressed, in congestive heart failure, this is a good example, I think, of --
of how the blood is not flowing forward vigorously, and every organ of the body suffers because of that. Just kind of puffing along there.
Q. And what happened to this individual, doctor?
A. This -- this particular gentleman, approximately two months after we did this procedure, died.
MR. MARTIN: Your Honor, I'm going to object to this question. I believe that's not relevant.
THE COURT: Sustained.
Q. You may continue, doctor.
A. Oh. This patient -- we mentioned --
Q. No, you may not answer that question. You may proceed with the tape.
A. Oh, I'm sorry.
Q. Okay.
A. The next patient that we're going to see was a -- is a 29 -- or was at the time of this angiogram a 29-year-old smoker. We talked yesterday about clots, of rupturing of plaque in an artery and forming a clot. This patient presented with, through a physician in southern Minnesota -- and a lot of people, I think, would have discounted his story being that he was very young and all -- this woman was an excellent physician and says this sounds bad, sent him directly to us, and we took him to the catheterization laboratory. And this is -- this is what we saw. But look again, mostly focus our attention on the very big, important, left anterior descending coronary artery, which in all of us is probably our most important artery.
And you'll notice -- and the first shot is kind of off the top of this screen. But you'll notice there is a density in the left anterior descending artery. Here, the artery -- here and here, you'll notice that there -- there's something not right there, that there's a hole in that artery looks like. What that is is a blood clot sitting there. And this patient had a very small plaque that, because he was in what we call a hypercoagulable state or had angry platelets, formed a huge blood clot on that -- when he ruptured that plaque, and then that artery was -- was essentially almost occluded from that.
Q. And doctor, if I could interrupt you one moment, are angry platelets or sticky platelets one of the mechanisms by which smoking causes coronary artery disease?
A. We think it's -- it's the biggest mechanism for presentation of an event. There -- as we described yesterday with our four major presentations or reasons of cause of atherosclerosis, once that plaque ruptures, then in people whose platelets are turned on or the angry platelets, then have that skinned knee in the artery, tend to have an exaggerated response to that knee -- skinned knee.
Now I'm just going to kind of let this run here and show you -- because you need to kind of see that area kind of jiggle here, there's an area there that kind of -- that to even an inexperienced observer -- and this is, again, the artery here, with a branch of that artery coming out that -- that has very slow flow. If you look here, these arteries are full and this one's only half full. Again, look here, there's a clot sitting right here, and it's impeded the flow down this artery. These arteries have already filled up, but this one is essentially blocked off at its branch point.
And -- and you'll see, as we dissolve this clot, that that artery gets better. And again here, you'll see there's just a little haziness right -- I got to get the right shot -- and we take a number of different projections of the same thing.
And again, if you look right here and watch as -- as it comes through, you'll -- you'll actually see a little backward and forward motion as that clot is sitting in the artery.
And so we -- we had a dilemma. And his right coronary artery again is normal, a nice-looking, normal right coronary artery here feeding the bottom wall of the heart, as we would expect in a 29-year-old, but with that we -- we had a dilemma on what to do with this patient. Again, his heart is pumping well. There's a little sluggishness right where that -- right here where that branch artery comes off. And you'll see here there's a little sluggishness where that branch comes off as to how the heart pumps. Okay?
So what we then did, we took a couple more pictures here of that, and then we started giving a medicine called urokinase, which is a clot-dissolving medicine, and as we --
Again I think you can see pretty clearly that there's a density in that artery. And as we give -- I'm just going to let this run now -- as we give the clot-dissolving medicine over a period of hours, that clot goes away, and the artery, this is post-urokinase, this is after urokinase, you can see that branch artery now fills up and that clot is gone. And we as clinicians who spend time in the Cath Lab understand that people who present with acute coronary syndromes in -- in this -- we brought the patient back after diffusing this overnight, and you'll see now that that area, in what we call the left anterior descending up here and here, now looks normal. If you just pulled them out, you'd say this was a normal angiogram. Okay? Because the clot is gone. We've given the clot-dissolving medicine and the clot is gone.
And this is what happens this smokers. This is a fairly dramatic example. We see it oftentimes in middle-aged women, 50-year-old women who come in who have a documented heart attack, and then when we finish with them, giving the clot-dissolving medicine, it looks like a normal angiogram. By the time we see blockages on an angiogram -- and this is again that patient that was restudied again because -- the next day to show that he had --
And again if you'd look at that, you would say that is a nice, normal- looking pipe, and this is what -- this is plumbing. We need to get blood to the heart. And again that branch artery fills up very nicely.
So then this is the clot that we see. This is the exaggerated clotting response that we see in smokers.
Q. And we see a normal pumping action on this 29-year-old.
A. Right. He has just a minimal ding on his heart where the -- where the area right up here doesn't pump quite as well as it should. It's gotten better with the resolution of that, though; that's something that a cardiologist would see.
All right.
Q. And could you describe for us the circumstances with patient two.
A. This will be the third patient actually.
I want to say that patient has stopped smoking -- this was about three years ago -- has not had any more clinical problems.
MR. MARTIN: Your Honor, I object to that gratuitous comment.
THE COURT: Sustained.
Q. You may proceed with the patient three, then, doctor.
A. Okay. This next patient is a 45-year-old female who presented with an acute heart attack. She was a smoker, had some family history of coronary artery disease, but had felt well until the day of her event. She was given what's called tissue plasminogen activator, TPA, which is a clot-dissolving medicine which is given in emergency rooms throughout the state of Minnesota for those people who get there in time. And again, she was in the 70 percent who -- whose artery opened up, but she didn't come to the emergency room for about six to seven hours until she had pain because she didn't think that she possibly could be having a heart attack. It's very common, especially in young people who don't realize the impact that smoking can have on this clotting ability and who just say this couldn't be me.
So we -- we will look at her angiogram now. And, you know, on first look it doesn't -- doesn't look too bad, but if you look and -- and in this resolution here it may be a little difficult to see, but she has about a 50 percent to 60 percent blockage. Again this left anterior descending coronary artery coming down the front of her heart here, after the clot has gone, she has about a 50, 60 percent blockage there and there, and it's not -- doesn't -- people could say how can I have a heart attack with a 50 or 60 percent blockage? Because she had mostly clot there being in this high-clotting state, and she -- and she came into the emergency room later --
MR. MARTIN: Your Honor, I'm going to object to this narrative. It's going beyond explaining what's happening here, what the jury is looking at.
THE COURT: No, no, I think that's --
You can continue.
A. Okay. Thank you. I'm just trying to fill in some clinical information.
And again here in this view, it looks hardly significant at all. But that's why we take many different views -- and this was an angiogram with the camera swinging around and all -- that we do.
And we will then show -- again there's that little blockage up in the first part of the LAD. The right coronary looks pretty normal for -- not for a 45- year-old, but there's no blockages, you know, per se, that are -- that are tight at this time.
The thing that's concerning about this woman, if you look at the front wall of her heart here, in what's called the ventriculogram, and here, this is the area fed by the LAD that wraps around the front wall of the heart. We'll go back on that. You can receive it's not -- it's not contracting. And I'm just going to go back and then we'll let it play again. The front wall of the heart doesn't move and she has lost that heart muscle. And with that, her risk of having -- if she has a second heart attack -- she's a woman age 45 that we're trying to get to age 80 with a good quality of life. If she has ever any problems in the right coronary or circumflex, her chances of sudden cardiac death are extremely high, because she needs so much muscle to push and her chances of dying before getting to the hospital are now 50 percent.
The next patient.
Q. Can you describe the circumstances of patient three when they presented to you.
A. This next patient was a 55-year-old woman smoker who was fine until she had developed a small heart attack on the bottom wall of her heart. She was stabilized in an outstate Minnesota hospital and then transferred to the Minneapolis Heart Institute for further care. She had, despite attempts to medically wean off the intravenous drips and all, she continued to have pain and then was taken because of that to the catheterization laboratory.
And you can see, just on first look here, that she has what we call multivessel coronary artery disease. And this woman was fine until the day before she came in. And I think there's a reason to talk about events versus disease. There's a blockage here in the circumflex, the LAD has multiple blockages coming down here and over here, the circumflex artery actually is in the back of the heart. The left anterior descending coming down has multiple blockages. I'm just going to let it play. You can get a feeling that there are -- that there are significant blockages all up and down this woman's coronary artery tree.
Q. And can we tell that, doctor, because we don't see those big, thick, juicy arteries that we saw in the previous patient?
A. Right. The arteries appear almost to kind of stop and start. And -- and there should be a big, white column of contrast that we see in a normal artery. But there are severe blockages. And again, this is a plumbing problem.
Interestingly, although there are severe damages on the left side and all these blockages, her culprit artery was actually the right coronary artery.
Okay.
We look again at the LAD here, you can see the significant narrowing up and down here in the branches there. We take numerous shots. And what we're doing is we're finding places for surgeons to bypass, because this patient has multivessel coronary disease. Every vessel has severe blockage. This is the type of patient who is best served by coronary bypass surgery.
And we're going to show the right here. And again, I -- I don't think you have to be a boarded cardiologist to see the interruptions in the pipe along the way here. And -- and if the blood doesn't get to the heart, the heart muscles --
And this was actually her acute lesion, or the blockage that caused her to present clinically. One wonders how somebody like this could be walking around fine, but we see that every day.
And because of this, this patient was then recommended for bypass surgery, because each -- each of the vessels had -- in looking for both symptom relief and longevity, extending her life, she was best served by bypass surgery because she had three- vessel disease, the right, circumflex, and --
And you can see the bottom wall of her heart in this localized area here is not contracting very well. And it's maybe an ejection fraction of 45, the normal being --
So this woman was then bypassed, but she had problems after bypass. Her heart raced, okay, and we needed to give her medications to slow her heart down.
Now we -- you'll see what a patient looks like after a bypass. You will notice that there are some wires in the chest which we use, and there are these clips here where, when we harvest a vein from the leg, we put clips on the vein on the side branches so they don't leak. This is again her native left anterior descending coronary artery post-bypass now. We first will inject the graft on the -- or excuse me, her native coronary artery, which becomes smaller as -- as we put by-passes into them.
Q. So these are the arteries now that the blood is by passing; is that correct?
A. Right. This --
And you can see that the right coronary, it was big down here, now looks small because the bypass has taken over for -- for the artery. But if the patient loses the bypass grafts, then the patient is in big trouble.
I'm just going to let these play on her native here. This is another shot of the right coronary artery here.
Q. You don't need to stop this the film, doctor, but could you explain -- you don't need to stop it. But could you just explain what see in the middle of those pictures?
A. If you look here and here -- we get used to these things -- and those are -- those are wires that we put around the sternum when the surgeon closes the chest. When -- when the chest is opened with a special type of saw, it's a broken bone, essentially, and we have to stabilize that in order -- any broken bone takes at least six weeks to heal, and so as we see then after a bypass, you'll see patients who have these wires that stay, then, in for life.
What you'll -- what you'll see also now in this picture is a bypass graft. We've now taken a vein from the leg and inserted at one end on the aorta, where we use special bypass graft catheters to inject that, and then it goes down to the native coronary. So again, much as we see here in the model, we have gone and we now are injecting dye into the bypass graft.
Q. And you're referring to Exhibit 30016.
A. Yes, ma'am.
Okay. So I'm going to show you just --
And her by-passes were open, although she was still having these rhythm problems. We were concerned that the rhythm problems were secondary to low blood flow to the heart.
That's a vein there, and then it goes into the native coronary artery. The veins at this point, just a couple months after, look big, and a vein is bigger than an artery and there's a little flow mismatch with that.
She had quit smoking by this time and she, you know, was -- and most people do very well post-bypass, but not everybody does.
Again the veins going to -- you can see the difference in size between the vein and the native coronary artery.
And then there's another vein to a different branch of the artery. And the surgeons sew those in while the heart is stopped and the patient is on a bypass machine. This is a vein to the right coronary artery here downstream, and that right coronary artery. And this is the left internal mammary artery which we take off the chest wall and put into the -- into the left anterior descending. I'll show that to you again. This is an arterial conduit that we try and use whenever we can, an arterial tube that we take off -- actually off the inside of the chest wall and swing it over. We think this has a better long-term patency than veins. But that's the left internal mammary to the left anterior descending down here.
We take a couple of shots of that. And we put a special catheter up there and engage that.
Q. And doctor, if a patient does not stop smoking, what is the risk to these new veins of these bypassed arteries?
A. We know post-bypass that 60 percent of bypass grafts of the venous type will be gone by ten years. So oftentimes people --
About 16 percent of our cases of what we call redo's. We -- we now know that the two biggest risk factors for early vein closure are continued smoking and untreated cholesterol. And -- and so, you know, we are very, very, very vigorous in our patient population, especially post-bypass, trying to get them to quit smoking because these graphs are now their lifeline.
And you'll see a different type of catheter injecting the right coronary artery graft feeding the bottom wall of the heart from a couple different views.
And although this patient's grafts were open, which also sometimes happens post-bypass, her heart just -- if you can look at it, remember what you saw before -- is not pumping as well as it did before. And -- and so just from the bypass procedure itself she has had some -- some heart muscle damage in a generalized fashion. The ejection fraction would probably be considered about 30 to 35 percent, where it was 45 percent before.
This woman continued to have arrythmia problems as far as her -- her arrythmia meaning her heart was racing, and we had to give her medications to slow down the heart. When we did that, the heart actually slowed down too much, and with that she required then -- when people's hearts go too slow, a permanent pacemaker, which I showed you yesterday. These are the pacemaker leads now in the right side of the heart. This is the --
Q. Could you show that on each screen, the pacemaker in the heart.
A. Excuse me. This is the ventricular lead which goes down and paces the ventricle, the right ventricle and subsequently the left ventricle, this is the atrial lead, which is in the shape of a J, up on top of the heart. Okay?
So this patient has now required a permanent pacemaker to -- because her heart was racing, we needed to slow down the heart, the heart slowed too much, and so we needed a safety net at the -- to keep the heart from going too slow.
Q. Doctor, can you remind us of the age of this particular patient?
A. She was 55 when she presented. And unfortunately, most of these complications happen in the first year.
And you can see now her heart is, again, not beating quite as well as it should. You can see the pacemaker leads. And with severe disease that she still has in her native coronary arteries -- I'm just going to let this play through -- her grafts are still open. But you can still see the severe nature of her diffuse coronary artery disease here.
That's the right coronary. Kind of ends there now. And with the graft in place, the right coronary is essentially closed. So if she ever does lose the right graft, she's going to be in big trouble because she's become what we call graft-dependent. This is the graph -- the saphenous venous graft to the left side of the heart you can see here, going into an artery that's smaller than the vein. And again you see just -- they look like ropes going in, and they -- they tie in. And there's the left internal mammary artery again coming down to the distal LAD here.
So this -- as we've stated before, this patient took a lot of care after her bypass, and this is not, you know, out of the realm of -- of normal for patients who become high-maintenance patients once they cross the line with symptomatic atherosclerosis.
Q. And does this patient remain at risk for congestive heart failure?
A. She is in congestive heart failure. I mean again her -- her pump is not pumping well, and so she is on medications that open the vessels downstream and make it easier for her heart to push forward so she does not congest and push the blood back into her lungs.
I'll just let that play out there.
Q. Okay.
A. These again the grafts, again all open. And so just from the wear and tear -- and none of these, as I said yesterday, are cures. For appropriately selected patients they are, I think, wonderful treatments and all, but I think none of them are what we would call cures.
Q. Now let's talk what I believe is our last patient; is that correct?
A. Yes. This was a 48-year-old gentleman from western Minnesota, very active businessman, had his own business. Presented with progressive chest discomfort. Had what we call a high risk positive stress test, an abnormal treadmill test, and because that was referred by his primary care physician for an angiogram.
Q. Doctor, was this 48-year-old gentleman a smoker?
A. Yes, ma'am.
With that you can see -- again we'll pay most attention here to the left anterior descending coming down here. There is a -- and we'll see it in a couple different views. There's a tight blockage in the left anterior descending up here.
Q. Show that on both screens.
A. Right -- right up here. And we'll see it in another view here that -- that I think will demonstrate it. And the next view I think will demonstrate it very well.
You can see here -- my pointer is starting to go -- that there's a tight blockage here, and in this area of the branched artery coming off there, right here, and into this branch artery here, that was giving him the symptoms.
Again, if this closes, all of the muscle downstream from that dies. This is referred in the cardiologist -- cardiovascular literature as the widow-maker lesion. It should be called also a widower-maker lesion because more women will die of cardiovascular disease in Minnesota than men.
So this was a very active gentleman who obviously had his own business, did not want to go to the operating room. We discussed these options of, again, medicines which were not -- which had failed, first angioplasty, first bypass surgery. He had his own business, really did not want to go into an operation. His right coronary was normal, his circumflex was normal. And his heart pumps normally, so he has not had a heart attack. And your long-term prognosis --
coronary disease, again, is linked to how well your heart pumps and how many vessels are involved as far as problems.
So what we did after a thorough discussion with this patient of the risks and benefits, we took him back to the catheterization laboratory later that day, and you'll see a scouting shot here again showing that blockage in the left anterior descending. My pointer is going. Again there's that tight, tight blockage on the left-hand side of the screen. And then you'll see my partner, John Lesser, did what was called a directional atherectomy of this lesion.
Q. Now Dr. Graham, this atherectomy, is that that knife that you put into the small coronary --
A. Yeah. This is a little cutter device, and we actually cut the lesion or the blockage. And it goes into kind of a capsule, and then we take it actually outside the body. Okay? This is a very complex procedure. You'll see that there's now a wire down the left anterior descending coronary artery, there's a guide here, and -- and then there's this device, this cutting device here. And you'll see it in motion, you'll see it actually go across, and there he's making a cut right now as it goes across. He's cutting the blockage out from the inside out.
Q. And how long does it take him for -- to do that cutting?
A. This procedure took about an hour and a half to two hours. He goes downstream and cuts a little further now. You see the little cutting device go through. And we keep bumping, we keep testing under the fluoroscope to check our results as we go along.
Then there's a lesion in the branch artery also that comes off -- it looks like the top there. And he puts -- he now puts the cutter in the branch artery and is cutting that. And you'll see now the -- the -- the wire -- my pointer is going here, I don't know if we have another one or not -- but the wire is going down the -- the branch artery, not the LAD. And it looks kind of simple and stuff, but to pull a wire back and then to put it back down the branch artery and not have the artery to close and stuff takes years and years of training to do that. And this -- this was, I think --
And now there's a balloon that we follow up with when we do these procedures usually. You can see there's a -- I'm going to get to the spot here --
Q. And just to remind us, is this the 48-year-old smoker?
A. Yes.
You can see here that there's a balloon in the artery. Now I'll just let it play.
The angioplasty balloon that I showed you yesterday is now inflated in the artery to stretch it after you do the cutting. And again, he's got the wire down the diagonal branch of the LAD. He's now put the wire back down the LAD. Again, we don't show all the in-between shots and all. But it's not easy to do that.
And -- and then we're checking our results. And then at the end, we take a final shot, and you see we've got a very nice result in this area here -- again my pointer is gone -- here, which was tightly blocked before is now wide open. And also here, it was tightly blocked before, is now wide open. Okay.
And so the patient went out and was doing well, but then in about three months started getting recurrent discomfort. And he was -- he exhibited what we call restenosis.
Q. And could you remind us what restenosis is, doctor?
A. I'll show you, I won't remind you.
And we'll look in so we're looking at kind of the same views. And now this patient -- remember, we had the branch point here and this is the diagonal, now there's a tight blockage right downstream from here, one of the places -- so one of the three places that we have cut has reclosed.
Q. And doctor, is that caused by scarring from the cutting machine?
A. Yes. This is --
Some people when they -- when they cut their hands heal up slick as a whistle, other people get a big scar. And we don't know exactly why that happens in coronary arteries, but there is at least a 30 percent chance of what we call restenosis with angioplasty and these cutting devices, and this patient had that.
Again, he ran his own business, he didn't want to be out of business. With the beauty of a -- of a catheter-based procedure, the patients go home the next day, and the day after they can go back to work, as opposed to when the chest is opened, they're out of work for six weeks to two months usually.
And with that, I'm just going to let this play through. We give some nitroglycerin to make the artery look bigger. And you see again that severe blockage there. And what we decided to do again after prolonged discussion was to re-cut that one area and try and open it back up, because this man really did not want to have a bypass surgery at age 48 years old.
So you see the cutting device is again placed across in the LAD, and we do a localized cutting to that one area that had scarred back in. You can see the cut goes back and forth. And we actually take the material out of the body and -- and send it off to the pathologist.
And now we can sometimes see clots, we sometimes see what we call hard atheromata, but it again depends on the situation. And again, I think you'll see -- Dr. Lesser did this procedure also -- you know, we had just a very nice initial result to -- to try and get this artery open.
Q. Now is the risk of restenosis a risk that can repeat itself again and again?
A. Yeah. In fact once somebody has restenosed --
You see there the results technically was excellent.
The first time the chance is 30 percent. When you go back like this the chance is 50 percent. And as to the discussions that we have with patients, and -- and some patients, you know, opt for surgery at that point, other patients, such as this person, was running his own business says, you know, "If I can possibly avoid it, I want to avoid it."
And -- and so again we had, you know, what we call was a technically very satisfactory result. Unfortunately, he came back about six months later with -- with recurrent pain, and at this point has, I think you'll see, developed some more scarring in that area. It doesn't show as well here. But we thought that this area was moderately -- this area in one view was severely -- and he needed to go for a two-vessel bypass at that point.
And again our -- for selective patients, these procedures are -- are wonderful, but again they are not cures. And these patients become oftentimes chronic patients who come back, you know, time and again.
You'll see here now this pump --
His anterior wall or his front wall of the heart is just a little bit sluggish there, the front wall, and that was one of the reasons that pushed us to go to bypass in this person.
Q. Thank you, doctor. You can resume your spot on the stand.
Dr. Graham, what is the greatest cause of death in the state of Minnesota?
A. Far and away the greatest cause of death in the state of Minnesota is cardiovascular disease.
Q. And what is the greatest preventable cause of cardiovascular disease?
A. Cigarette smoking.
Q. What would be the impact on your practice as a clinical cardiologist over the next five years if there was no smoking?
MR. MARTIN: Objection, lack of foundation.
THE COURT: No, you may answer that.
A. We think about those things and -- but we estimate, looking at how many of the patients are active smokers when they come to us and how people can change their risk by stopping smoking, that if -- if from this day forward there was no smoking, that within a five-year period our volumes would decrease by half.
MS. NELSON: No further questions, Your Honor.
THE COURT: Why don't we take a short recess.
THE CLERK: Court stands in recess.
(Recess)
THE CLERK: All rise. Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
THE COURT: Counsel.
MR. MARTIN: Ladies and gentlemen, good morning.
(Collective "Good morning.")
BY MR. MARTIN:
Q. Dr. Graham, good morning.
A. Good morning.
Q. My name is David Martin. I represent the Lorillard Tobacco Company, and I'm going to be asking you the questions on behalf of the defendants today.
In your testimony yesterday you talked about four primary factors, and you wrote them down here on the chart, and I have left them there. I believe you said the four primary factors were smoking, cholesterol, hypertension, and diabetes; is that correct?
A. Yes, sir.
Q. And today when you finished your discussion you talked about the elimination of smoking as a risk factor, and so because you've done that, I would like to talk about all four of these factors, but I would like to talk about the three that are left, cholesterol, diabetes, and hypertension. Do that?
The first of those is cholesterol. Cholesterol is one of the major problems in American society today; isn't it, high cholesterol?
A. Cholesterol is a risk factor/causative agent for the development of coronary artery disease.
Q. All right. And it is a risk factor that is shared by over 50 percent of the population; isn't it, high serum cholesterol?
A. I would say dyslipidemia is a problem in the fact that some people have high levels of the good cholesterol -- or excuse me, high levels of the bad cholesterol, which is the LDL cholesterol; other people have low levels of the good cholesterol, which is HDL cholesterol.
Q. Doctor, you, I believe, for a time were a member of the Board of Directors of the American Heart Association, the Minnesota affiliate.
A. Yes.
Q. Do you recall that?
A. Yes, sir.
Q. That was from 1990 to 1992?
A. Yes, sir.
Q. And when you prepared the report which you gave to us prior to your testimony, you cited a number of documents as references upon which have you relied in preparing the report; didn't you?
A. Yes, sir.
Q. And you have a book in front of you of defendants' exhibits, and one of those, tab number 51, which is the last tab in the large notebook, which is exhibit number CN000046, I'd like you to look at that.
A. 51?
Q. 51, the last tab, Exhibit CN000046.
A. Yes, sir.
Q. This is a publication of the American Heart Association?
A. Yes, sir.
Q. And it is in fact a document which you labeled as one of your references when you prepared your report; is that correct?
A. Yes, sir.
MR. MARTIN: We would offer CN000046.
MS. NELSON: No objection, Your Honor.
THE COURT: Court will receive CN000046.
BY MR. MARTIN:
Q. Now the front of this document simply indicates what it is, "Heart and Stroke Facts: 1996 Statistical Supplement."
And the American Heart Association has been in the business for quite some time of keeping track of things like cholesterol rates, levels and -- and vital statistics related to heart disease; is that correct?
A. I'm not aware of how long they've been in business.
Q. Well to assist us in talking about some of these things, why don't we turn to page 18. And the document page numbers are in the left-hand corner. And let's take the top of the page on the left side, "Cholesterol." Can you read there where it says that "Estimates are that 96 million American adults (52.1 percent) have blood cholesterol levels of 200 milligrams per decaliter and higher, and about 37.8 million American adults (20.5 percent) have levels of 240 or above." See that?
A. Yes, sir.
Q. Do you agree with that statement?
A. I -- I would agree. We in our practice never use a total cholesterol. In a clinical presentation of medicine, if you think about it, the body has no total cholesterol, and in the clinical practice of medicine there is the good cholesterol, HDL cholesterol, the bad cholesterol, LDL cholesterol, and what we call the ugly cholesterol, which is a triglycerides. So as a clinician we never use that to make decisions on whether patients are at risk for coronary artery disease or what the treatment should be.
This is used for populations and by empidemiologists and biostatisticians, and I am here to testify about the clinical treatment of coronary artery disease.
Q. Now many of the people that you see in your practice are over the age of 65; aren't they?
A. Yes.
Q. And generally speaking, as a rule, we can say that the older population has a higher total cholesterol rate?
A. I don't think --
Again, I -- I'm not here to testify about population studies and total cholesterol levels because a total cholesterol level is not something we use in the clinical practice of cardiology.
Q. If we turn to page 19 of this exhibit, you'll see a chart here which shows the estimated percentage of Americans aged 20 and over with serum cholesterol of 200 milligrams or more, and it's by age, sex and race. And if we look at the top right-hand corner -- we'll take it up to the right-hand corner on the top, and if we could blow that up just a little bit, little bigger, we see that the -- and if you move it over so we get the 65 to 75 -- 65 to 74 age group, and this is broken down by non-Hispanic black males, non-Hispanic white females, non-Hispanic black females and non-Hispanic white males. You'll see that all of these rates run at least above 61 percent and some as high as 80 percent of total cholesterol; correct?
MS. NELSON: Objection, Your Honor, this goes beyond the scope of the direct, and there's a lack of foundation. The witness has testified about his expertise.
THE COURT: Well you can answer that question.
A. As far as your reference to the page, I -- I agree with the statistics as stated.
Q. Then let's talk about one of the other factors that you look at when a patient walks in the door, has had a coronary event. Do you look at whether they're overweight or not?
A. We do.
Q. And if we turn to page 20, we see here on a chart marked "Overweight" -- and if we can blow that up on the top -- an estimated 61 million American adults are 20 percent or more above their desirable weight, 20 percent or more above their desirable weight.
Is that a factor that you look at when a person comes in to determine whether or not they have been at a risk for developing heart disease?
A. We -- we look at many factors. And if you would --
If we would complete the sentence that you started, that it would also note there's an increase of 36 percent over the 1960-to-'62 examination data, the same period which coronary artery disease has decreased in this country dramatically.
Q. Well we see that people are much more overweight than they used to be, but you're saying the coronary artery disease has decreased.
A. I think that speaks, sir, to that weight per se is not as potent a risk factor as smoking, as hypertension, or diabetes mylodus, and of certain kinds of cholesterol abnormalities. I think it goes to argue that the big four are the big four, which most clinicians return to consistently, which have been shown to be causative agents. And when you add those one to another, there is a synergistic or additive effect to those that increases the risk of a patient presenting with their first event or with returning with another more serious event.
Q. All right. So then let's look at high blood pressure on page 12, if we could. "About 50 million Americans age 6 and older have high blood pressure."
Can you blow that up a little more on the left side?
"About 50 million Americans age 6 and older have high blood pressure.
"One in four American adults has high blood pressure."
These are heavy risk facts for development of the disease; aren't they?
A. Hypertension alone has some impact. As we --
If we go back to the model we talked about yesterday of the wheat field, hypertension, when it is present, you know, pounds on a coronary artery and is a risk factor for progression of disease.
I would point out that we need blood pressure to a certain degree. We need cholesterol. Every cell in our body's cell wall has cholesterol in it. We need blood sugar. If you have too low a blood sugar you get shaky, and if you have too high, of course, it's diabetes.
So those three entities that are up are physiologic entities, which means that we have them, we need them, and it's an imbalance of those that causes a problem.
Cigarette smoke, there is nothing physiologic about that. That is an irritant that gives a toxic impetus to the development and progression of coronary artery disease.
MR. MARTIN: I'm going to object to the last sentence of the question as not responsive -- or the answer as not responsive. Move it be struck.
THE COURT: No, the answer -- the last sentence is not responsive.
BY MR. MARTIN:
Q. Doctor, I know that you want to discuss smoking, and we will. I'd like to discuss these three that are left once you eliminate smoking first. Okay?
A. Yes, sir.
Q. In high blood pressure -- and if you'll -- if you'll turn to page 13, one in four Americans have high blood -- suffer from high blood pressure, and 20 million are age six and over. And on the left-hand corner you see "Awareness, Treatment and Control Rates," and if we can blow that up so we can look at that, as I read that chart, 46 percent of the people in 1976-1980 were unaware that they had high blood pressure, and in the '88-to-'91 years, 35 percent have no idea that they have high blood pressure. Have I read that correctly?
A. I think you have.
Q. And that is a real risk factor to these individuals, to not know that they have high blood pressure; correct?
A. As any that is unaddressed is.
Q. And the second column shows "On Medication, Controlled," and so for these last years we have 21 percent that have controlled high blood pressure by medication. I read that correctly?
A. No, I think that -- excuse me. "On Medication, Controlled," 21 percent. Yes.
And again, I think we're getting somewhat out of the scope of, you know, clinical practice of cardiology in the state of Minnesota.
Q. Did I read it correctly?
A. Yes, sir.
Q. All right. And 27 percent are on medication, but their high blood pressure is still uncontrolled, according to the chart.
A. Yes, sir.
Q. And apparently 17 percent aren't on medication at all. Even though they have high blood pressure and they're aware of it, they're simply not on the medication; is that correct?
A. Yes, sir.
Q. So we have 35 percent have no idea that they have high blood pressure, 27 percent, they know it and they're on medication but uncontrolled, and 17 percent, they know it, but they're not on medication at all. And that's of one in four Americans. Is that correct?
A. Yes.
Q. You talked about diabetes as another risk factor of the big four. Would it be correct to say that diabetes becomes a risk factor the longer that you have it, and so it is the length of the disease as opposed to, say, the intensity of the diabetes in terms of cardiovascular disease?
A. I do -- I do not think that that's uniformly true.
Q. Do you know approximately how many Americans suffer from diabetes?
A. It depends on your definition of diabetes. There -- as you know, diabetes is a -- an abnormality of blood glucose or blood sugar where the -- where the sugar rises. With that there are various definitions that people would -- criteria, whether people are treated by diet, whether you consider somebody a diabetic who is treated by pills or insulin.
Q. And every one of these individuals, however they are being treated, are at some greater risk of developing cardiovascular disease.
A. Yes, sir.
Q. I'd like to talk a little bit about some other factors that played a role in these three risk factors, if we could.
You talked about cholesterol. Diet is an absolute element of cholesterol control; isn't it?
A. Yes.
Q. It is -- it is one. Is it the only one?
A. No. There are genetics, there's exercise.
Q. You brought up genetics, and that's one factor that we didn't talk about as a risk factor. But when you take a history, when someone comes in with an event and they're able to tell you about what is happening to them, one of the issues that you ask them is a question about whether their parents suffered any kind of heart disease; isn't it?
A. Yes, sir.
Q. And that's an easy question to try to determine whether or not they have some genetic predisposition to development of this disease; is that correct?
A. Yes, sir.
Q. And genetics is something that you cannot take out of that risk-factor package; can you?
A. Some of the genetics of coronary artery disease are from inherited metabolism diseases of cholesterol, which we can treat, so we can change family history over time.
Q. You can change family habits.
A. No, we can change the heart -- if --
If a father has a cholesterol of 300 and we are presented with an early heart attack, we can treat the cholesterol in the offspring of that person who passed genetically that cholesterol abnormality on, and over time the family history of coronary artery disease can change.
Q. Another risk factor, depending upon how it's used, is alcohol; isn't it?
A. Alcohol can be -- is viewed by many as beneficial.
Q. Depends on how much you drink?
A. Yes, sir.
Q. So one to two drinks a day may be beneficial, and more than one or two drinks a day would be a negative in the development of this disease, coronary vascular disease?
A. It can be in certain populations.
Q. It would increase the risk of developing coronary vascular disease; correct?
A. In certain individuals it may.
Q. So we'll say "alcohol use (excessive)." And that covers that as a risk factor; correct?
A. I think that, again, you --
We're getting into areas which would become controversial as we get -- stray away from our major four.
Q. How about oral contraceptives, is that a risk factor for women?
A. Oral contraceptives are more a risk factor for venous thrombosis, which means a clotting on the venous side, not the arterial side.
Q. And how about stressful life events?
A. Again, we are getting into areas of controversy here as far as stress and the quantitation of stress, how that impacts each individual. One person's stress may be invigorating to another person. So again, I think we're -- when we stray -- start straying away from the major risk factors previously outlined, you begin to get into areas of controversy.
Q. Clearly there are those that say that women with post-menopausal estrogen deficiency are at a higher risk; aren't they?
A. Post-menopausal --
Menopause is defined as a lack of estrogen in a woman's body. At menopause a woman's ovaries stop producing estrogen, and so the definition that's used is a little off. Everybody who is post-menopausal has an estrogen deficiency. Whether we supplement a woman with estrogen in order to decrease her cardiovascular risk, decrease her loss of bone, becomes an individual clinical decision that is made with a clinician and that woman.
Q. So when a clinician is dealing with somebody about the possibility of the development of coronary artery disease, they have to evaluate, among other things, their sex and their age; don't they?
A. That is part of the equation.
Q. And these become risk factors as we get older; don't they?
A. Sex does not become a risk factor. The common misconception is that coronary artery disease is a men's disease. As I stated earlier, more women will die of coronary artery disease in this state this year than men. So sex is not a risk factor. And it is the people who persist in those stereotypes that keeps the public from being educated appropriately, and the women that we see, then, are surprised that they have coronary artery disease.
Q. Women live longer than men in Minnesota; don't they?
A. As a rule.
Q. And probably in the United States, as a rule?
A. I'm not privy to those information.
Q. And when they start to talk about the risk of a person developing coronary artery disease, if you're evaluating somebody, when they get older you say that their risk of developing it has gone up; is that correct?
A. Yes, sir.
Q. And if you're trying to evaluate men on the one hand and women on the other hand, you would say age is a criteria of whether you might develop coronary artery disease. You start over or under 45 as a critical age point; don't you?
A. I -- I think, again, you need to return to the -- the bedside and to the patient. The people that --
If that woman internist in southern Minnesota had looked at that 29-year- old and said you're too young to have coronary disease, he may have very well gone out and died. So the trick is individualizing patient care. So that we take a thorough history, a thorough physical examination, and decide with the patient and the clinician what is best for that individual patient.
Q. With respect to trying to evaluate a population or a group of individuals, and you were trying to come up with just some basic numbers here, aren't you in agreement that, generally speaking, people look at the risk for a man higher when they're over 45, lower when they're under 45?
MS. NELSON: Objection, outside of the scope of direct. Dr. Graham made it clear he's not an epidemiologist.
THE COURT: Sustained.
Q. Let me talk about a few more possible risk factors. Have you ever heard of amino acid homocysteine?
A. Yes, sir.
Q. In fact, you gave an interview about some findings with respect to certain levels of amino acid homocysteine in the newspaper; didn't you?
A. Yes, sir.
Q. And as I understand that interview --
And if you'd like to see the newspaper article, you can turn to tab 19. It's document CN000025.
MS. NELSON: Counsel, CN000015 is not in this.
MR. MARTIN: 25.
BY MR. MARTIN:
Q. As I understand the study that was referred to in that interview, that they found high levels of acid -- of amino acid homocysteine in younger men who had suffered heart attacks, and believed that perhaps that would be a predictor or a cause of that heart disease; is that correct?
A. There is a relationship of homocysteinemia to --
We find an abnormal level in about 30 percent of patients 55 and under, both men and women, who have presented with clinical coronary artery events.
The homocysteine is a protein that if your body does not break down in a proper mechanism, that can build up in the system. We have started looking at this in patients who have known disease because of the high risk of those patients, if they have a further event, dying from their disease. We treat the abnormalities that we find, but we do not know at this time whether a treatment has a beneficial effect. But because the patients are at such high risk once they've had a coronary event, especially these young patients that we're trying to get to live not six months or a year but trying to get to live for a decade, we offer them something that very much might -- may correct the abnormality; we don't know that if correcting the abnormality causes them to live longer. And I would juxtapose that to studies of smoking, cholesterol, LDL cholesterol, hypertension, and diabetes, where studies have shown in those conditions that modifying the risk factor or withdrawing the causative agent has a definite impact on the outcome of the disease.
MR. MARTIN: I move to strike the last portion as being non-responsive to the question that was asked.
THE COURT: No, that's responsive.
BY MR. MARTIN:
Q. Doctor, looking at tab number 19, Exhibit CN000025, that is from The Star and Tribune, page E3, Health & Fitness, and does that contain the newspaper story which refers to you in it?
A. Yes, sir.
Q. And it refers to your discussion about homocysteine.
A. Yeah. It's a very brief, little clip.
MR. MARTIN: We'll offer CN000025.
MS. NELSON: Objection, Your Honor, this is not the best evidence. The witness has already testified to the topic. It's an improper use of the exhibit.
THE COURT: The court will receive CN000025.
BY MR. MARTIN:
Q. Now this article indicates, "You're probably at risk of developing heart disease fairly early in life if you have abnormally high levels of amino acid homocysteine, according to a study at Abbott Northwestern Hospital."
That's your hospital; correct?
A. Abbott Northwestern is our hospital. But that was the writer's words, not our words.
Q. And the article goes on to say, "Researchers there found about 30 percent of seriously ill heart patients in their 30s and 40s had high levels of amino acid in their bodies, and 40 percent had high serum cholesterol levels." Correct? I read that correctly?
A. You read it correctly, but it was not quoted correctly.
Q. Doctor, I read in the newspaper yesterday about a study about streptococcus bacteria being released when one brushes their teeth. Did you happen to see that article?
A. I did not read the paper yesterday.
Q. It was in the paper on Monday as well.
A. Okay.
Q. Are you familiar with this study that dealt with brushing your teeth -- teeth and releasing streptococcus bacteria being a risk of a heart attack?
A. I am not familiar with the study.
Q. Doctor, all of the things that we've talked about contribute to the risk of heart disease; don't they?
A. I -- I don't know that we can say a blanket statement for the clinical practice, that they -- my own clinical practice, that in our individual patients they would contribute to the risks of all the things that you've talked about.
Q. Your own clinical practice essentially deals with people who have come to you after they've suffered some sort of a coronary event.
A. No.
Q. They are making some complain of pain?
A. We see a full spectrum of consultive cardiology from people with congenital heart disease, to people with valvular problems, all the way -- we have a -- see high-risk primary prevention patients who may have significant risk factors or causative agents that they want to address so that they don't end up in our coronary care unit. We see all the realm of cardiovascular disease as far as inflammation around the heart, diseases of other blood vessels.
So while a majority of the patients have had a cardiac event, it is not correct to say that they have all had a cardiac event.
Q. I understand from your resume that one of your titles or one of the positions that you hold is director of preventative cardiology at Minneapolis Heart Institute.
A. Yes, sir.
Q. And preventative cardiology is in fact one of your passions; isn't it?
A. I don't know if I would call it a passion or not, but it's -- it's an area of intellectual interest.
Q. And in preventative cardiology, what you're trying to do is to prevent the need for the kinds of treatment that you have talked about today; is that correct?
A. Yes, sir.
Q. I believe that you at one time said in your deposition that any family practitioner, any doctor in medicine is in effect a preventative cardiologist.
MS. NELSON: Objection, Your Honor, improper use of a deposition.
THE COURT: Sustained.
MR. MARTIN: I'll withdraw the question.
BY MR. MARTIN:
Q. Do you agree that any general family practice doctor in practice today is a preventative cardiologist?
A. I would not agree that they are a preventative cardiologist.
Q. Do you believe that anyone who practices medicine is a preventative cardiologist?
A. I do not agree that anyone who practices medicine is a preventative cardiologist.
Q. Do you believe that they should be a preventative cardiologist?
A. I do believe that everybody should be a preventative cardiologist.
Q. And is the best cardiology preventative cardiology?
A. It depends, I think, on the clinical situation. If somebody comes in with an acute heart attack, the best preventative -- the best cardiology may be getting a wire down their LAD and opening it up quickly. So it depends again, on an individual patient that we see in a practice, what they need at that particular time.
Q. In terms of preventative cardiology, I believe that you speak to groups from time to time about the best things that they can do to reduce the risk factors.
A. Yes, sir.
Q. And some of the messages that you carry to them revolve around sedentary lifestyles?
A. Yes, sir.
Q. And you believe that it is absolutely imperative to prevent coronary artery disease to have a minimum level of exercise every week; don't you?
A. We recommend to patients as part of a preventive regimen that they aim for 200 minutes of exercise a week. That's five days, 40 minutes a day. It's in line with the American Heart Association recommendations.
Q. And that doesn't have to be running a marathon; does it?
A. In fact we recommend what -- the type of exercise to do is what people like, because if you don't like what you're doing, you are not going to do it long term.
Q. So walking 40 minutes a day would --
Fast walking 40 minutes a day would meet that criteria?
A. Yes, sir.
Q. Another control for high cholesterol and to try to avoid becoming a coronary heart patient is diet coupled with that exercise; is that correct?
A. As I --
Again, as I've stated, we do not use a cholesterol in our practice. We use the word dyslipidemia and use the bad cholesterol, the LDL cholesterol, the good cholesterol, HDL, and the triglycerides, which is a measure of the free- floating fat in the blood.
Q. HDL, the good cholesterol, that's one of the reasons you're exercising.
A. Yes.
Q. Exercise increases HDL; correct?
A. Over months, yes.
Q. And with respect to some of the other cholesterols, what you want to do is have a different kind of diet than a fatty-foods diet. Eat more fruits and vegetables; isn't that what we hear?
A. There is an American Heart Association Step One Diet which we recommend to patients. We generally aim for 40 to 50 grams of fat per day. We will also aim for increased fiber intake and very -- at least five portions of fruits and vegetables per day.
Q. And is that effective to reduce the bad cholesterol?
A. Studies will show that anywhere from five to 20 percent reductions, depending on where the patient is starting with in their diet, of the bad cholesterol with a heart-healthy diet.
Q. Is it fair to say, doctor, that you would recommend the American Heart Association Step One Diet to everyone in the American population?
A. We think -- and I'm relying on experts who have conceived and recommended the diet -- that it is -- that it is a healthy diet.
Q. Would you recommend it to every one in the American population?
MS. NELSON: Objection, Your Honor, asked and answered.
THE COURT: It's been asked and answered.
Q. That diet would have a positive impact on coronary heart disease; wouldn't it?
A. We -- we think a heart-healthy diet will have an impact on coronary artery disease.
Q. Have you done any work with respect to body shapes?
A. Could you restate the question?
Q. Sure. Sure.
Let me throw out a couple of different kinds of body shapes, and I'll -- I'll take my hand and try to write them down on here.
Sometimes we see reference to an individual as a -- and again I'm going to have to apologize for my writing. But I'll put an apple, little head on it, couple legs, and then a pear, with a little head on it, shape, as being two different types of shapes that -- people come in all sizes and different shapes, but that's two different kinds. Do you agree with that?
A. It's a conception. It is a model.
Q. Okay. And from time to time you've referred to pear-shaped individuals and apple-shaped individuals when you talk about preventative cardiology or trying to assess risk factors for individuals; correct?
A. There is an association of certain body shapes with other abnormalities that predispose people to coronary artery disease.
Q. Would you turn to tab 29, which is exhibit number SM000027. Do you have it? Tab 29.
A. Twenty-nine? I don't have it.
Q. Do you have it now?
A. Yes, sir.
Q. And do you recall that between March 19th and the 22nd of 1995, you presented an abstract to the Journal of the American College of Cardiology?
A. I have to make sure that it's here.
Q. It would be on the third page, the right side.
A. Yes, the abstract is contained in this.
Q. It's contained in this exhibit?
A. Yeah, in this exhibit, yes, sir.
MR. MARTIN: We would offer Exhibit No. SN000027.
MS. NELSON: No objection under 803(18), Your Honor.
THE COURT: Court will receive SN000027.
BY MR. MARTIN:
Q. And can we turn to the third page, to abstract 982-116, "Gender-related Differences in Risk Factors of Young Patients with Symptomatic -- Symptomatic Coronary Artery Disease."
What does "symptomatic coronary artery disease" mean?
A. Symptomatic coronary artery disease means that the patient has angina, has presented with an event as far as angina, chest pain, a heart attack, unstable angina, many of the events that we talked about here yesterday and this morning, so that they have symptoms that led them to see the doctor relating to their heart.
Q. So this study was made of individuals who came to Abbott Northwestern, came to your practice, and they had a complaint relating -- which suggested they were suffering coronary artery disease; correct?
A. Yes, sir.
Q. And this is a study of 732 of those individuals; correct?
A. Yes, sir.
Q. And what you did was you took the data and you tried to see if there were any conclusions or thoughts that you might draw from looking at some of the background data of these 732 individuals; correct?
A. Yes, sir.
Q. And one of the things that made this important is they were all under 55 years of age; is that correct?
A. Yes. We were looking in this study at, first, defining why people showed up, not only the first time but the second and third time, with coronary artery disease.
Q. And let's look at the risk factors that you looked at: current smoking, high blood pressure, family history of heart disease, diabetes, sedentary lifestyle, total cholesterol, and increased waist-to-hip ratio. And one of the things that we find there is that of the men, 75 percent had a sedentary lifestyle, and 86 of the women -- 86 percent of the women had a sedentary lifestyle; is that correct?
A. Yes, sir.
Q. And we also found -- or you also found or noted here that the increased waist/hip ratio for men was 78 percent and women 75 percent; is that correct?
A. Yes, sir.
Q. Now you drew some conclusions about the importance of just those two factors; didn't you?
A. The purpose of this, and -- and I think there is a danger which the scientific community would usually not discuss at length in abstract, because an abstract is, by nature of the limited size and limited wordage, a -- a condensation of -- of a work. And so I think there is an inherent danger in speaking about abstracts, because the reason you go to present an abstract is to expand on the findings and -- and explain what you've said.
People will not quote in a scientific journal abstracts because they are these, if you would, micro look at a very large body of data. So the --
Drawing conclusions from reading this is erroneous. The reason these are presented at major scientific sessions is that people go -- and this is a teaser, if you would, to say I need to find out more about this, so then people go to the session. And either this was a poster session where we put the material up, and then there is a further, more detailed discussion of this that does it more scientific justice.
This would not be quoted by another article in a scientific peer-reviewed journal because it is just an abstract. So I think there are dangers of lifting things out of here that are -- unless we spend a lot of time going over more of the data.
Q. Okay. So what I understand you're saying, this wasn't peer reviewed, it wasn't --
A. No, this is peer reviewed, but it is an abstract. And I think, not being in the medical community, there is a danger of the lay public to grab onto these things as gospel. And -- and there's a lay -- danger in the press, such as you saw, to take a small bit of information that then comes out and becomes what may be seen as -- as -- to the lay public as a big story. And -- and that's why rigorous scientists will not spend a lot of time unless an abstract then goes on to publication.
Q. The data that's contained in here is from Abbott Northwestern Hospital where you are employed; is that correct? Where your practice exists?
A. Yes, sir.
Q. And there were actually 732 consecutive patients on which this is based under the age of 55; is that correct?
A. Yes, sir.
Q. Consecutive is important, because you didn't just pick and choose. The first 732 that came in; correct?
A. Yes, sir.
Q. And you were reporting this to cardiologists to take a look at; correct?
MS. NELSON: Objection. Objection, asked and answered.
THE COURT: No, you may answer that.
A. Yes, sir. Cardiologists, internists come to -- nurses. A wide variety of cardiovascular specialists come.
Q. And when you reported this information to them, one of the things under number six you reported was total cholesterol; correct?
A. Again, in a limited space. And I think it would be fair to the jury --
MR. MARTIN: Your Honor, I'm going to object to this as not responsive to the question that was asked.
THE COURT: Counsel, don't interrupt the witness. I have no idea whether it was responsive when you interrupt part of his answer. I'll hear his answer.
A. In a limited space we did not have literally room to put the breakdowns of the good, bad, and ugly cholesterol in there between the different groups. And again, this is a danger of using an abstract to make a lot of decisions from, because it is literally, you know, condensed into a very small space where every word is precious. And when we do that, you make decisions on what to put in and what not to put in. And then the presentation of an abstract at a scientific session, either verbally or by poster, is what is really accepted.
Q. So I'll ask the question again. You put in total cholesterol; correct?
A. Because of space limitations, we put in total cholesterol.
Q. I would like to ask you to turn to tab 30, which is Exhibit SM000028. Do you have it?
A. Thirty.
Q. Tab 30.
A. Yeah.
Q. This is a Star and Tribune article dated Wednesday, March 22, 1995. That's the same year -- that's the last day of this conference entitled "Reducing your heart-attack risk."
Did you give an interview to the Star and Tribune with respect to this abstract and the presentation at the seminar?
A. Yes, sir.
Can -- can I take a second and read this? I haven't seen this in years.
Q. Certainly.
A. Okay. Thank you.
MR. MARTIN: Your Honor, while he's reading, I would offer SM000028.
MS. NELSON: Objection. For what purpose? This is --
He can ask the witness the testimony. It's not the best evidence.
THE COURT: Why don't we give him a chance to read it so we know if it's accurate or not.
THE WITNESS: Okay.
Q. Have you had a chance to read it?
A. Yes.
MR. MARTIN: Your Honor, we'd offer SM000028.
MS. NELSON: Objection, no foundation as to its accuracy.
THE COURT: Yes. Could you lay some foundation, counsel?
BY MR. MARTIN:
Q. Following your presentation at the American College of Cardiology seminar, did you give an interview to the Star and Tribune on Wednesday, March 22, '95, or perhaps the day or so before that?
A. I can't remember what the timing was.
Q. But you did give such an interview.
A. Yes, sir.
Q. And there is a Dr. Kevin Graham, director of preventative cardiology at the Minneapolis Heart Institute, who is quoted extensively in that article. Is that you, sir?
A. It would be me.
Q. And at the time when you gave that interview, did you speak truthfully as you understood the data at that point?
A. Yes, sir.
Q. And did you expand a little bit on the abstract which we have been discussing?
A. As I stated before, there is a large body of data that in the abstract is a tip of the iceberg, and so various parts that we had talked about and expanded about in the presentation were discussed in the -- in the article.
MR. MARTIN: We'd offer the article.
MS. NELSON: Same objection, Your Honor. There isn't a basis that the article is accurate and complete.
THE COURT: Can we find out whether he's been quoted accurately?
MR. MARTIN: Well we can quote it to him and have him find out.
THE COURT: Counsel, the question is simple.
MR. MARTIN: I'm sorry.
THE COURT: I just asked -- ask the witness whether the quotes in the article are accurate quotes.
BY MR. MARTIN:
Q. You've read the article now, doctor. Are those accurate quotes?
A. Just give me a second and I'll read the quotes again.
Yes, they're reasonably accurate quotes.
MR. MARTIN: We would offer it, Your Honor.
THE COURT: All right. Court will receive SM000028.
BY MR. MARTIN:
Q. Now doctor, I would note that this article is entitled "Reducing your heart-attack risk," and then "Study: Inactivity, abdominal obesity common in patients." Did I read that correctly?
A. Yes, sir.
Q. Do you believe that's an accurate representation of your study?
MS. NELSON: Your Honor, the article that appears on the screen is not the same article that was produced to counsel. SM000028 does not appear in that form.
MR. MARTIN: Your Honor, we've given them both the Internet form and the --
MS. NELSON: You have the incorrect exhibit number, counsel, because the form that you're now showing for the jury which has not been admitted for this jury.
Your Honor, I'd ask that it be removed from the screen until we clarify this.
THE COURT: Take it off the screen for now, please.
MR. MARTIN: Your Honor, may I approach the witness and look at his?
THE COURT: Yes.
MR. MARTIN: Your Honor, he has the correct one. And if I might, I can give plaintiffs' counsel the same copy.
MS. NELSON: Well I think the point, Your Honor, and I could compare the two, is that the SM000028 that was designated to us was the different copy.
THE COURT: Okay. I wonder if we could pass over this exhibit to give plaintiffs' counsel a chance to review the new copy, and then you could continue your inquiry after lunch. Would that be all right?
MR. MARTIN: That would be fine, Your Honor.
THE COURT: That won't interfere with your cross?
MR. MARTIN: We can move on.
THE COURT: Or else --
MR. MARTIN: Or we could break for lunch a little early.
THE COURT: Okay. Why don't we break for lunch now, then, and recess, reconvene at 1:30.
THE CLERK: Court stands in recess.
Recess
THE CLERK: All rise. Ramsey County District Court is again in session.
THE CLERK: Please be seated.
THE COURT: Counsel.
MR. MARTIN: Good afternoon.
BY MR. MARTIN:
Q. Good afternoon, doctor.
A. Good afternoon.
Q. When we took our noon break we were discussing the findings which you had presented at the conference of the American College of Cardiology. Do you recall that discussion?
A. Yes, sir.
Q. And in the abstract, a copy of which was on the -- was in front of us for a moment there, you had made a finding that 75 percent of the men and 86 percent of the women led or had a sedentary lifestyle. Do you see that? It's number five, sedentary lifestyle.
A. Yes, sir.
Q. Can you define "sedentary lifestyle" for me and for the jury.
A. We gave a routine questionnaire to these people asking them if they walked regularly, if they did any outside activity outside of routine daily activity, and that's how it was defined.
Q. And you say you gave the questionnaire to them. What's the cutoff point? What's sedentary? What's the next step up, if you will, in terms of activity?
A. Walking, any organized extracurricular physical activity. There were a whole list of things. "Sedentary" means that they were not active outside of their jobs and their routine physical activities of life.
Q. All right. Now I believe we concluded we were talking about an interview which you gave to the Star and Tribune, and if you'll turn to tab 30, which is Exhibit SM000028. Do you have that in front of you?
A. Yes, I do.
MS. NELSON: Your Honor, we have had an opportunity to compare the exhibits, and they compare properly.
THE COURT: All right.
MR. MARTIN: And we would offer SM000028.
MS. NELSON: No objection, Your Honor.
THE COURT: Court will receive SM000028.
BY MR. MARTIN:
Q. Now the headline on this article in the Star and Tribune on Wednesday, March 22nd, 1995, was "Reducing your heart-attack risk. Study: Inactivity, abdominal obesity common in patients." And if you look at the paragraph in the first column, it makes reference to a Dr. Kevin Graham, director of preventative cardiology at the Minnesota Heart Institute. Is that you?
A. That is I.
Q. And if I read it, it says, "Dr. Kevin Graham," and lists your title, "said the finding could be a lifesaver for relatively young heart patients."
Is that what you told this reporter?
A. I do not believe I worded that. I think that as much as the abstract is a condensation of knowledge that then blossoms forth, a newspaper article is a condensation of an hour discussion that then is condensed into what that writer that day thinks will catch his or her readers' interest.
What we said and, what I believe I said to the patient is -- or to the writer, it's not a patient, is that addressing this syndrome could be lifesaving to patients.
The truncal obesity syndrome, the apple shape, is associated with high triglycerides or the free- floating fat in the blood, tends to be associated with low HDL or good cholesterols, tends to have a tendency towards mild glucose intolerance or mildly abnormal blood sugars, and tends to have a tendency towards high blood pressure. And it's been well defined in the literature as Syndrome X. Each of those are what's called the deadly limbs of a cross.
The ultimate result of those things is that the patient is hypercoagulable, and that the blood is sticky, and so when a young patient presents with this syndrome, they tend to present, much like in smoking, with a lot of blood clot in the artery.
If you add cigarettes on top of this syndrome, it is like throwing gas on a fire. And that's something like the 29-year-old that I showed you with that clot in the artery. So addressing this syndrome, as far as decreasing the -- how you wear -- not your weight, but how you wear your weight, and decreasing the -- by exercise and by losing five pounds, exercise redistributes weight, it does not make you lose weight unless you do a whole lot of exercise, so with that there is -- there was a relationship between this body form and high triglycerides and low HDL which predisposed people to this clotting abnormality. As cardiologists we were aware of this. We wanted to make the rest of the world aware of this.
What has happened is in -- and we're in a -- you must understand, in a group of patients with known disease, we're in a battle to keep them alive, so we give them aspirin in order to try and grease the platelets, but we need to do everything we can to keep the clots from forming. This is an attempt to say to those people -- and I think what he took from context is that -- is that if we can decrease the clotting state by losing weight, by redistributing weight, by bringing down the triglycerides, bringing up the HDL cholesterol, controlling the blood glucose, when the weight comes down that happens, and stopping smoking, you have a better chance of being alive.
Q. Okay. Doctor, looking at your abstract again, if we might, the risk factors --
A. Which number would that be?
A. And that would be tab number 25, exhibit SM000027. You see risk factor number one, current smoking?
A. Twenty-five is -- is not -- it's not tab 25.
Q. Tab 29.
A. Twenty-nine. Okay. Yes, sir.
Q. See "Current Smoking" under "Risk Factors?"
A. Yes, sir.
Q. So 63 percent of the men did not smoke; did they?
A. At the time this was collected, this was current smokers who were smoking at the time of hospitalization. In truth, 90 percent of the men and 95 percent of the females had been smokers in their lives. And again, this is your, you know, risk of reading an abstract and not getting all the information.
This is all comers who come into the hospital. Many of them we've been successful to get them to quit smoking, or they felt poorly over the two months before because they were developing chest pains and they stopped smoking on their own because they knew something was wrong.
Q. Dr. Graham, does your abstract say under "Risk Factors, Current Smoking," that 63 percent of the men were not currently smoking?
MS. NELSON: Objection, asked and answered, Your Honor.
THE COURT: I think it's been asked and answered.
Q. Am I reading this correctly, doctor? Does the risk factor say current smoking with respect to women, 57 percent of the women are not smoking?
MS. NELSON: Objection, asked and answered.
THE COURT: I believe he just answered the question, counsel.
MR. MARTIN: This was with respect to women, Your Honor.
Q. In your article --
And let's turn back to tab 30, Exhibit SM000028. I'm sorry, not your article, but the interview. Do you have it?
A. Yes, sir.
Q. And let's look at the portion that appears on the second page, page 1A, which is the lower part of the exhibit. And in the first column, in the second- from-the-bottom paragraph, it says, "The most common occupations among patients: law enforcement and truck driving."
A. Yes.
Q. That was information that was also not included in the abstract; was it?
A. Yes, sir.
Q. And then there is, with quotes around it, quote, "'It's understandable,' Graham said. 'Both are sedentary, policemen and truck drivers tend to eat fatty foods, and both are under considerable pressure,"' close quote.
A. Yes, sir.
Q. That's a statement that you made; isn't it?
A. I believe that's in essence what I said.
Q. And so job pressure was also a factor that was important to you in analyzing the heart attack risk of these individuals; wasn't it?
A. I think what we --
We actually did a survey as part of that, and that was more of a subjective measure on my own part rather than an objective measure. We did what was called a Holmes & Reye stress scale with each patient who was entered into this registry, and the Holmes & Reye stress scale starts with rating stresses in patients' lives, starting with getting a hundred points for death of a spouse, certain number of points for job change, and a gradation scale down from a hundred all the way down to low-grade irritations which we all go through which count for not -- not as many points.
With that -- and by objective measurement, we were not able to show that there was a definite correlation between stress -- and this is part of the things which I talked about earlier today as far as being into a little shakier ground -- and the presentation with acute coronary events.
Q. You felt it was important to tell The Star and Tribune reporter that the policemen and the truck drivers were under considerable pressure.
MS. NELSON: Objection, argumentative, Your Honor. Asked and answered.
THE COURT: You can answer that.
A. I -- I think that this was a personal feeling of myself, because I think we've heard that a lot from -- from truck drivers and policemen, that they are under a lot of stress.
Q. Look on the second column, that same page, and the second paragraph, quote, "'Sedentary lifestyle and truncal obesity were by far the most prevalent risk factors,' close quote, Graham said."
You made that statement?
A. I think --
I cannot, obviously, remember back in 1995. Again, we have defined those as not essentially risk factors, but things that cause accentuation of other risk factors.
If you have, again, the apple shape, although your cholesterol may not be high -- and this is why we never use a total cholesterol in clinical settings, you again tend to have high triglycerides, which is a measure of the free- floating fat, a low HDL cholesterol, tend to have blood sugars that may range from 115 to 140, or -- that's a role that's borderline for diabetes but is not categorized as diabetes, tend to have high blood pressure. These are not risk factors in -- I should say the ultimate result of that is hypercoagulable state and premature coronary events. These are not risk factors in themselves, but they, much like smoking does, put the risk of the other ones at a higher level. So you have dyslipidemia -- which is a better term, really, than high cholesterol -- diabetes, high blood pressure, the three other risk factors which are listed there are made worse by this body syndrome.
Q. Is truncal obesity, is that the increased waist-to-hip ratio?
A. Yes, sir.
Q. And that means that the waist is bigger than the hips?
A. Greater than .85 in males and greater than .95 in females.
Q. But you don't call that a risk factor?
A. No, it's not. It's correlated with a risk. It accentuates, as I said, these other risk factors. The borderline diabetes. As weight continues to be gained, the patient may actually develop frank diabetes. It accentuates high blood pressure, it accentuates high triglycerides and low HDL cholesterol. And all of these things then are what we call part of the big four.
Q. And doctor, if you'll turn back again to tab 29, your Exhibit SM000027, which again is the abstract you published, and there you list the risk factors; don't you?
A. Yes, sir.
Q. And as the risk factors, you list current smoking, high blood pressure, family history of heart disease, diabetes, sedentary lifestyle, total cholesterol, and increased waist-to-hip ratio.
A. Yes, sir.
Q. And in the article you say that 25 percent of the women -- I believe 50 percent of the women had four or more of these risk factors; is that correct?
A. Yes, sir.
Q. And the men had three or more of these risk factors.
A. In the abstract, not the article. I think I heard you say "abstract," or was it -- did you say --
Could you repeat it?
Q. I'm sorry. In the abstract that we're looking at, you say that 50 percent of the females had four or more of the risk factors; correct?
A. Yes, sir.
Q. And the risk factors that you're referring to is the list of seven which appears on the screen here.
A. And again, I think that you are hanging your hat on an abstract. And if you could see, again, every tenth of an inch of space is -- is competed for there, and -- and I think what we looked at, really, is how the five separated from the two, but there really wasn't space to do that. In the poster presentation that was differentiated.
Q. Let's go to -- back to the article -- I'm sorry, the interview, Star and Tribune interview.
A. Yes, sir.
Q. Tab 30, SM000028, third column of the second page, there's a statement there, "The patients meet with nutritionists and other specialists to discuss risk reduction during their three-month visits and are asked to return for a followup, including exams, every year thereafter."
And then the following paragraph, quote, "'We want to change their diet,' close quote, he said. Quote, 'We want them to walk,' close quote."
Did these patients return for yearly followups?
A. Do they return?
Q. Yes.
A. We --
About 40 percent of patients return for the initial three-month followup. At the Minneapolis Heart Institute, as I explained yesterday, we have 28 outreach referral sites that we physically go to, we see patients from all over the Upper Midwest, from South Dakota, North Dakota, Iowa, far -- as far over as -- as Green Bay, Wisconsin, we will see referral patients who come to us for specialty care that we can give that other centers may not be able to give. We find that the referral pattern and their rate of return is correlated to the length of distance the patient lives from us. We have --
Because of that loss of some patients coming back or being -- we have now set up a web-based followup, which we're going to implement in the next six months, so that primary care physicians will have the same specialty information that we have.
And to directly answer your question, the ones that do not come back usually are the ones that live greater than a hundred miles away.
Q. And with respect to those people that do come back and are engaged in this process with you after two years, what's your success rate in terms of changing their diet and increasing their exercise activity?
A. We are --
In order not to look at our results prematurely, we are going to follow all of these patients for four to five years out and -- and then look at the data and then in a qualitative and quantitative fashion say who has changed their various risk factors, causative agents for coronary disease, what was the greatest impact of that -- of what intervention.
So we offer the highest quality of care and the same information to all the patients who return, but we have not statistically looked at that as of yet.
Q. So you don't know what your success rate is in terms of just whether or not people are no longer living a sedentary lifestyle.
MS. NELSON: Objection, asked and answered, Your Honor.
THE COURT: I think it's been asked and answered, counsel.
BY MR. MARTIN:
Q. Let's talk a little bit about the procedure that you showed us some film of today, the angioplasty.
A. Okay. The case of angioplasty.
Q. All right. As I understand that, you could do 10, maybe 12 of those a day?
A. Certain days.
Q. And many times the patient goes home and doesn't even stay overnight.
A. Usually the standard of care is the patient goes home the next morning, usually.
Q. Let's look at -- let's just stay with SM000028, tab 30. On that last paragraph down on the bottom of the third line, it says, "He said that those who merely undergo balloon angioplasty, when an inflated balloon is used to widen narrow stretches of coronary arteries, are often sent home the same day, and that the people who undergo coronary artery bypass operations often go home within a few days."
Is that an accurate statement?
A. No. What I said was people who get an angiogram -- and again, non- experts merge an angiogram, which is the diagnostic procedure to say where are the blockages in the arteries, versus the interventional procedure. Patient --
There is about -- approximately a one percent rate of what we call abrupt closure after we do an angioplasty. It's only one in a hundred, but because of that most patients stay in the -- in the hospital over the evening because you've not only have gone in through the femoral -- right femoral artery up there, so you have a hole there, but you also have an area of injury in the heart. So most patients will stay in the hospital overnight with an angioplasty.
With the diagnostic test, which is an angiogram, most of those patients will go home that day.
Q. And when they undergo that process, I take it that many times there's insufficient time for a doctor to sit down with them and talk about changing diet or changing habits; is that correct?
A. There -- there is not insufficient time for -- from a physician's standpoint. The problem is what -- what happens with -- with patients is we give them medicines -- you can imagine you don't want to be wide awake when somebody's sticking a needle and putting novocaine in your right groin, and so we give patients medicine, although short-acting, they don't wear off right away.
In our first groups of patients that we would send home, in what we call our under 55 registry, the patients that came back were the ones who had bypass surgery. Because then when we called back and asked many of the patients who didn't come back, they said, "What appointment?" And it turns out that many of those patients -- and we've changed how we do our dietary counseling, how we do our exercise counseling because of that, because their spouses or significant others would remember what we told them, but they don't remember because they have these what I call the shroud of valium and seconal, the drugs we give them, they don't wear off as soon as we come out of the room. Some of them take three to four days for the metabolites of those drugs to wear off. So we actually -- whether the patient goes back to the primary care center or to the -- or comes back to see us at three months, we delay dietary and exercise treatment in people who have angiograms and angioplasties because it -- they understand it better when their heads are a little bit clearer.
Q. And these people have all just gotten a wake-up call because they've had a coronary event; is that correct?
A. Well not all have had a coronary event. Some just have angina. Some you study and they have disease that's not critical. But they -- most of them are there for a very good reason.
Q. And this followup that you do with them in terms of changing their diet, changing their lifestyle, becoming more active, that is as important as the work that you did when they came in?
A. Risk-factor modification, getting after the causes that let them come in, can be more or less important. Each has to be judged by itself. If somebody has a life-threatening lesion, a blockage in a coronary artery, and you handle that blockage for them, that's pretty important. But we -- we then let the smoke clear and do the best job as we can in the acute studies, and then we turn our attention long term -- and again, every one of our cardiologists we consider preventive cardiologists -- to addressing the causative agents that got them there.
Q. If I understand your answer, then, it is important to modify behavior.
MS. NELSON: Objection, asked and answered.
THE COURT: You may answer that.
A. If --
Again, I would return to the -- to the patient. If there are behaviors that would best serve that patient by being modified, you know, that is -- is in the patient's best interests. We will do whatever it takes to keep that patient from coming back again.
Q. So each patient is an individual; is that correct?
A. I think it's obvious that each patient is an individual.
Q. And -- and you have to treat each individual based upon their own history and upon their own life experiences until they get to you; is that correct?
A. Every clinician who sees a patient treats that patient as an individual, and so regarding cardiac disease, we take the sum of a standard history and physical, the standard questions that we ask, our physical examination findings, we synthesize that material and try and give the best diagnosis and treatment that we can to that patient.
Q. And cardiac disease is the sum of a lifetime of exposure to certain risks; isn't it?
A. The development of blockages, as we talked about yesterday, is the -- is a chronic process most of the time that most people in this room have some element of. The presentation with disease is most often a sudden event from plaque rupture and then the clinical sequelae that come when that clot goes on there.
The more risk factors or causative agents that you have, synergistically build to develop the disease and to make the presentation more perilous.
Q. So the worst your diet, the less exercise --
A. Excuse me, I didn't hear what you said. Excuse me?
Q. The worst your diet, the more fatty foods, if I can -- if I can speak to that, the more red meats one eats, the less exercise one gets, the more stress one is subjected to, the older one is, all of these are factors which may contribute to this event.
A. Those are, again, in a limited sense --
An experienced clinician would not, you know, limit themselves -- if -- if you're going to ask the question of a patient, and that's what we're talking about, you ask all the questions.
Q. And one of those questions is whether they smoke or whether they don't smoke.
A. Yes. Or whether they have smoked.
Q. Or whether -- or whether they have smoked.
And one of those questions is how much they drink and when.
A. In a standard history and physical, alcohol consumption, tobacco consumption, allergies, all of those things, medication sensitivities, are all garnered.
Q. What they know about the death, if their mother or father are deceased, what they know about that death.
A. Yes, sir. And their brothers and sisters, uncles and aunts, and grandparents.
Q. Those are all indicators as to how susceptible they might be to coronary artery disease.
A. Again, the clinician uses a history before laying a stethoscope on the patient to make a pre-test assessment of the risk of that patient developing coronary artery disease. The four questions that we talked about that are asked first and foremost are diabetes, high blood pressure, dyslipidemia -- not hypercholesterlemia, because it takes in the other abnormalities of cholesterol also -- and smoking.
Q. Apparently you also ask about exercise.
A. Yes.
Q. And you also ask about their version of job stress, their opinion of their own job stress.
A. We're getting, again, into areas that are -- are grayer. As you -- as you --
The farther you get away from the big four, as you step away, you are getting away to an area that for --
A clinician needs to quantitate and move forward.
Q. When you discussed with the jury the coronary angiograms of the various patients that you were showing the various procedures, those were angiograms that -- films that you had selected from Abbott Northwestern; correct?
A. Yes, sir.
Q. And you selected them to show the procedure; didn't you?
A. I selected the angiograms to show the range of coronary artery disease that we would see in a typical day in the cardiac catheterization laboratory at Abbott Northwestern Hospital. These were not -- this is not anything unusual. They would be the same thing, maybe not quite as many in St. Joe's or United here in town, but this is how it goes.
Q. And with respect to those coronary angiograms, you told us a little bit about those people, but you didn't tell us whether there were any diabetics. You didn't tell us about cholesterol levels in any of the individuals. You told us their age and sex, and you told us that all but one had been a smoker.
You didn't tell us whether they were sedentary; did you?
A. I did not comment particularly on that.
Q. You didn't comment on whether or not they were an alcoholic or whether they used alcohol excessively; did you?
A. I did not.
Q. You didn't talk about their genetic predisposition --
A. No.
A. -- to the disease process; did you?
A. In some of those it was not available. But what I was showing the first four angiograms for was to show first a normal, then a grossly abnormal and a chronically scarred heart, an older individual. And you had mentioned age as a risk factor and what can happen as an old -- an individual ages. The third we wanted to demonstrate hypercoagulability, which I think we demonstrated nicely in that angiogram of the patient. The fourth, 45-year-old female, pre- menopausal, who did have an LDL cholesterol of 144, who was a smoker, was not of the Syndrome X variety. The fifth was a thin, 55-year-old white female smoker with an LDL cholesterol of 170, HDL cholesterol of 50 -- which is quite good -- who presented with significant coronary artery disease. The last was the 48-year-old gentleman who did have mild Syndrome X or truncal obesity, who was a smoker, who had suffered the consequences of clot on clot that a Syndrome X smoker would have.
So I was not meaning to hide any of the risk factors. And I -- on any of these patients, I'm more than willing to discuss them. Because, you know, I think we all know that people don't present to the cardiac catheterization laboratory with -- usually with one risk factor, and especially at a young age. It's multiple, synergistic risk factors, and you start adding one on the other, that causes the devastating events of coronary -- that can happen to these young people.
Q. And you could have found films which demonstrated all the things which you demonstrated to the jury from individuals who were non-smokers; couldn't you?
A. I would have had to look farther.
Maybe I can offer an example. Before I came in this morning, I --
MR. MARTIN: Your Honor, I'm going to object to this. There's no pending question.
THE WITNESS: Okay.
THE COURT: There is a pending question, counsel. Let him answer that.
A. Before I came in this morning, I had ten patients in the hospital which I went and rounded on. Of those ten patients, two have conditions that were not related to blockages in coronary arteries. One is a young woman with inflammation around her heart, such as the first gentleman we showed, 18-year- old who has pericarditis who also happens to be 36 weeks pregnant, she's in the hospital because of that. The second is a man who had a leaky mitral valve and had a surgery.
Of the other eight patients that -- that we saw -- that I saw this morning before I came, I was making mental notes, all of -- excuse me, not all, but seven of the eight had been or were smokers before they came into the hospital. And again, when you -- when you're at the bottom end of the funnel, when you see the devastation that happens with coronary artery disease and you see the predominance of smoking and you have the weight of, you know, every major medical society in the -- in the world, the nation, and in Minnesota, behind you, it doesn't take a board certified cardiologist to realize what devastating thing this is.
Q. Are you familiar with the National Health Enhancement Systems, Inc.?
A. I'm not.
Q. Would you turn to tab 28, Exhibit SM000026.
A. Twenty-eight?
Q. Twenty-eight.
Have you had an opportunity to look at it?
A. I -- I do see it's a three-page handout -- two-page handout. Excuse me.
Q. And have you ever, as a -- just as an individual, watched 20/20 on television and seen the heart test?
MS. NELSON: Objection, irrelevant, Your Honor.
THE COURT: Irrelevant.
MR. MARTIN: Your Honor, if I could lay foundation, I can tie it up.
THE COURT: Not through 20/20. Rephrase the question, please.
BY MR. MARTIN:
Q. Are you aware that there are certain questions and answers that are sometimes given to individuals to help them assess the possibility or probability of being at risk for a heart attack?
A. Yes.
Q. And you in fact participate in those kind of presentations from time to time; don't you?
A. Yes. It's part of the Minneapolis Heart Institute Foundation, which is the teaching and research arm of the Minneapolis Heart Institute. A couple of times a year we give a four- or five-part series of talks that is aimed at the lay public. And then they come in and have their blood taken at the first visit, and have their blood pressure taken. They fill out a questionnaire. Then we give them the results at the third or fourth visit when we go over the results; they have the results back by then. And then there's a compilation based on the Framingham heart study, which is an epidemiologic study in Framingham, Massachusetts. An epedimiologic study is where people look at a population but they don't do any intervention on them, they just look and see what happens. I'm not an epidemiologist, I can guarantee you that, but based on that data, they -- if you lived in Framingham, they would give you an estimate of what your coronary artery disease risk is.
There's risk in -- in a -- and the first thing I tell patients is there's risk in looking at any general survey. And again as clinicians we try and individualize what the patient's risks are. At the same time it gives them -- puts them in some general ballpark and gives them a basis to go back to their primary care physician and have a discussion about what really is their coronary artery disease risk.
Q. Do you recognize the second page of SM000026 as being the questions that you ask the attendees to fill out?
A. You know, when -- when we do these things, I usually speak at about the fourth session when the blood has come back, and this could be a survey that we have used in the past. I can't tell you that it is. It -- it's a standardized health care assessment survey. I can't swear to you that this is the one we use currently or have used.
Q. Let's leave that, then, and let me ask you this: What percentage of your patients are Medicaid patients?
A. I don't know, sir.
Q. Are you aware, under the court's supervision, there's been a sample of 15 Medicaid recipients in Minnesota that authorized the collection and review of their medical records for this case, and that those medical records were provided to lawyers for both the state and Blue Cross and Blue Shield?
MS. NELSON: Objection, outside the scope, Your Honor.
THE COURT: You can answer the question.
THE WITNESS: Pardon?
THE COURT: You may answer it.
A. I'm not aware of that.
Q. Are you aware that under this court's supervision a sample of 15 Medicaid recipients in Minnesota filled out certain questionnaires about their health and family histories and lifestyles for this case, and that those questionnaires were provided to the lawyers for the state and Blue Cross and Blue Shield?
A. No, sir.
Q. Are you aware that under this court's supervision a sample of the 15 Medicaid recipients in Minnesota testified under oath at depositions about their medical conditions, health histories, lifestyles and family health histories?
MS. NELSON: Objection, irrelevant, outside the scope.
THE COURT: No, you may answer.
A. I'm not.
Q. As a medical expert who is testifying in this case, were you asked by the lawyers for the state of Minnesota and Blue Cross and Blue Shield to review the medical records of the sample of the 15 Medicaid recipients in Minnesota who authorized the collection and review of their medical records?
A. You know, since I didn't know they existed, it would be very hard for me to review them.
Q. Did the lawyers for Blue Cross and Blue Shield give you any breakdown of records or histories and ask you to formulate any opinions or give them any opinions with respect to the 15 Medicaid recipients?
MS. NELSON: Your Honor, I object to this line of questioning. At this point the witness has made it clear that this is entirely outside of the scope of his work.
THE COURT: I think at this point in time it's clear that he wasn't given anything about the 15. Why don't we move on.
BY MR. MARTIN:
Q. Doctor, I believe that when you concluded your direct testimony, you indicated that cardiovascular disease was the number one killer in Minnesota in -- 1996 was it, did you say?
A. I think we were using 1992.
Q. 1992?
And it's true, isn't it, that it was the number one killer in 1991 and 1990?
A. Yes, sir.
Q. In fact it was the number one killer in the '80s and in the '70s and in the '60s; wasn't it?
A. No, sir. In 1972 pneumonia was actually a higher killer in Minnesota than cardiovascular diseases.
Q. What about nationwide?
A. Again, I think we're getting to biostatistics and other areas for decades that I think is outside of what I came to talk about with the presentation and the seriousness of coronary artery disease, peripheral vascular disease and stroke.
Q. Well in fact in the United States, isn't it true that every year except 1918, coronary vascular disease was the number one killer?
MS. NELSON: Objection, outside the scope.
THE COURT: No, you can answer it if you know.
A. I don't know. I have not reviewed back to 1918.
MR. MARTIN: I have no further questions.
THE COURT: Counsel, unless there's going to be intended use of the charts there, it probably would be appropriate as a matter of routine if we laid that down, because I think it interferes with some of the vision of some of the counsel. I mean it's all right if you're going the use it, but once we're finished using it, why don't we lay it down. And it will open it up.
MS. NELSON: It will take a moment to organize. Won't be but a minute.
BY MS. NELSON:
Q. Good afternoon, Dr. Graham.
A. Good afternoon.
Q. Turning your attention to what has been marked as SM000027, the abstract that counsel was talking to you about --
A. What number would that be in their book?
Q. I'm not certain.
MS. NELSON: Counsel, what number would that be in your book?
MR. MARTIN: It's 30, I believe.
THE COURT: No.
THE WITNESS: The abstract?
THE COURT: Twenty-nine?
THE WITNESS: Twenty-nine.
MR. MARTIN: Twenty-nine.
THE WITNESS: Okay.
Q. If you could turn to page two of that abstract, to Dr. Graham's abstract, and focus in on that, please. I believe you testified on cross, Dr. Graham, that if -- when you looked at the population of people who were the subject of this study, that 90 percent of men had smoked; is that correct?
A. Yes, ma'am.
Q. And 95 percent of the women had smoked?
A. Yes, ma'am.
Q. Did you reach a conclusion, therefore, in this study as to the single most causative agent of coronary artery disease?
A. Again, it would take a little bit of time to expand on all the results, but to give you a summation, current or former cigarette smoking was by far the most significant predictor of presentation with coronary artery disease.
Q. Now Dr. Graham, counsel addressed the education you provide for your patients after you've provided them with coronary care. What is the predominant warning that you give to patients who come back to learn about risk factors after coronary care?
A. If a patient is a smoker, we -- we send the messages to these patients that if you want to be alive in a year, the biggest thing you can do in the next year is to quit smoking, and that you decrease your risk of having a myocardial infarction and other events 50 percent in one year when you quit smoking. And the reason for that is is because the impact of smoking, when you get smoke out of the system and the platelets become less angry, if you would, if they do rupture a plaque in their coronary artery, they're less likely to form a clot on that plaque that would cause them to come back with an acute event, or worse, die suddenly outside the hospital. So the benefits of reducing your risk from smoking in one year is the biggest risk factor in prevention that you can do of any risk factors.
Q. Dr. Graham, you talked about the apple-body shape. Does smoking cause coronary heart disease in people regardless of body shape?
A. Of course. The reason we are more concerned and the reason people present at a younger age, it validates our -- our -- what we've been talking about the last two days, is that the people who are apple-shaped, who are predisposed to this, clot -- one clotting abnormality on top of another with the propensity to form clots from having the apple shape, plus the propensity to form more clots because of smoking and having a clotting holocaust, if you would. The smokers who do not have the apple shape tend to present a little later in life because they just have one set of clotting abnormalities on top of the plaque, and the plaque probably has to build to a little bigger shape before they present with that.
So we tend -- we tend to see the non-truncal obese smokers present a little bit later than the truncally obese smokers.
Q. I'd like to turn your attention, then, to CN000046, which would be the American Heart Association "Heart and Stroke Facts: 1996 Statistical Supplement" that counsel spent some time reviewing with you.
A. Is that 51? Okay.
Q. If you would turn to page 16, please. Counsel didn't mention the entries in this article about cigarette and tobacco smoke, and so to ensure that the jury gets all the information, I thought I would direct our attention here.
Am I reading this correctly, doctor: "Estimates are that in 1990 about 417,000 Americans died of smoking-related illnesses?"
A. Yes, ma'am.
Q. "Nearly one-fifth of deaths from cardiovascular diseases are attributable to smoking." Did I read that correctly?
A. Yes, ma'am.
Q. "It's also estimated that about 37,000 to 40,000 nonsmokers die each year from cardiovascular diseases as a result of exposure to environmental tobacco smoke." Is that correct, doctor?
A. Yes.
Q. How many people total died from cardiovascular death during 1990, the year to which this survey -- the year that this document is addressing?
A. I think the American Heart Association estimated about 954,000 total cardiovascular deaths in the United States in 1990.
Q. So if one-fifth of those deaths is from smoking, how many people in this country died from cardiovascular disease due to smoking in 1990?
A. I think that would figure out to about 191,000.
Q. And how many people in this country died that year from cardiovascular death due to exposure to secondhand smoke?
A. The estimate --
MR. MARTIN: Your Honor, I object, lack of foundation. This witness doesn't have competency to answer the question.
THE COURT: I think you're going to have to rephrase the question, counsel. Are you referring to the study?
MS. NELSON: Yes.
BY MS. NELSON:
Q. Based on the "Heart and Stroke Facts: Statistical Supplement" that defense counsel brought to your attention, based on that study, doctor, how many people in 1990 died from cardiovascular smoke due to environmental tobacco smoke?
A. The study quotes 37 to 40 thousand.
Q. So how many Americans died in 1990 from cardiovascular diseases due to smoking?
A. Roughly 230,000.
Q. Now if you'll look at the third bullet point in the American Heart Association fact study page, does that say, doctor, that in 1990, "Smoking- related illnesses cost the United States about 50 billion dollars annually in medical care?"
MR. MARTIN: Objection, beyond the scope of the cross.
THE COURT: Well you introduced the exhibit. They're entitled to discuss the exhibit. You may answer.
A. Yes, ma'am.
MS. NELSON: No further questions.
THE COURT: You're not quite done.
THE WITNESS: Oh, I'm sorry.
MR. MARTIN: Almost, doctor. Almost.
BY MR. MARTIN:
Q. Are you ready?
A. I'm ready.
Q. You do see people that don't smoke in your clinic?
A. Yes, sir.
Q. They do go through some of these same processes that you talked about. In fact all of them.
A. Yes, sir.
Q. What's the warning that you give the non-smoker who comes in who has suffered one of the coronary accidents you've talked about?
MS. NELSON: Objection, outside the scope of the redirect.
THE COURT: You may answer that.
A. We recommend diet, exercise. If their cholesterol is high, the LDL cholesterol, we try and lower that. If their triglycerides are high, we try and lower those and raise their HDL. So we -- we offer the same -- we address, again, individually every patient that comes along and address their modifiable risk factors.
Q. You talked about the American Heart Association document which counsel read from. She talked about the number of deaths. How many of those individuals did not have -- or did not present any of the other risk factors for cardiovascular disease?
A. I don't understand the question.
Q. You've indicated a certain number died of smoking-related diseases. How do you --
How many of those individuals also presented with problems related to high serum cholesterol, lack of exercise, truncal obesity, and the other related issues we've discussed?
MS. NELSON: Objection, outside the scope of the redirect. We were addressing the Heart Association's document, much like counsel did. It's also irrelevant.
THE COURT: Well I think you'll have to rephrase the question as it relates to the